Introduction Seasonal allergic rhinitis (SAR) symptoms are troublesome and may contribute to impaired quality of life (QoL). In a randomized, double-blind phase 2 study, fixed-dose combination of once-daily (QD) or twice-daily (BID) olopatadine hydrochloride/mometasone furoate nasal spray (GSP301) significantly improved average AM and PM reflective Total Nasal Symptom Scores (rTNSS; primary endpoint, presented elsewhere) vs placebo. Additional efficacy and QoL endpoints are reported here. Methods Patients with SAR (≥12 years; N=1,111) were equally randomized to GSP301 BID (olopatadine 665μg/mometasone 25μg), GSP301 QD (olopatadine 665μg/mometasone 50μg), olopatadine (665μg BID/QD), mometasone (25μg BID or 50μg QD), or placebo for 14 days. Mean change from baseline in average 12-hour AM and PM instantaneous TNSS (iTNSS), Physician-assessed Nasal Symptom Score (PNSS), and Rhinoconjunctivitis Quality of Life Questionnaire–Standardized Activities [RQLQ(S)] for GSP301 BID and QD vs placebo were analyzed using analysis of covariance (ANCOVA; P Results Compared with placebo, GSP301 BID and QD significantly improved iTNSS (least squares mean difference [97.5% CI] GSP301 BID: -1.11 [-1.65, -0.57]; QD: -1.11 [-1.64, -0.57]; PPPPP=0.005) vs placebo. Treatment-emergent AEs were 10.8%, 9.5%, and 8.2%, for GSP301 BID, QD, and placebo groups, respectively. Conclusions GSP301 BID and QD treatments provided statistically significant improvements in both SAR nasal symptoms and QoL vs placebo.

In patients with allergic rhinitis (AR), intranasal combination treatment with an antihistamine and a corticosteroid may provide improved symptom relief over monotherapy treatment. GSP301 nasal spray (NS) is a fixed-dose-combination of the antihistamine olopatadine hydrochloride and the corticosteroid mometasone furoate. Efficacy and safety of GSP301 once-daily (QD) or twice-daily (BID) were evaluated in this seasonal AR (SAR) study.

Background Ciclesonide hydrofluoroalkane nasal aerosol (CIC-HFA) is currently in development as a potential treatment for allergic rhinitis. The objective of this study was to determine the long-term safety and efficacy of CIC-HFA compared to placebo in subjects with perennial allergic rhinitis (PAR).

Background Ciclesonide hydrofluoroalkane nasal aerosol (CIC-HFA) is currently in development as a potential treatment for allergic rhinitis. The objective of this study was to determine the efficacy and safety of CIC-HFA compared to placebo in subjects with perennial allergic rhinitis (PAR).

RATIONALE: Quality of life was evaluated in subjects 18-64 years of age with seasonal allergic rhinitis (SAR) following 14 days of treatment with ciclesonide aqueous nasal spray (CIC-AQ), an intranasal corticosteroid, as measured by the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).METHODS: This was an analysis of data from a double-blind, placebo-controlled, multicenter, efficacy and safety study of 327 subjects ≥12 years of age with SAR (Ratner et al, J Allergy Clin Immunol, 2006) who received 200μg CIC-AQ (N=164) or placebo (N=163) QD AM for 28 days. Subject-assessed overall RQLQ using a 7 point scale (0=not troubled to 6=extremely troubled) for days 1-14 was a secondary endpoint in this study. Subjects were not required to have a minimum baseline RQLQ score (mean baseline RQLQ=3.87). An analysis of improvement in overall RQLQ and individual domains of RQLQ following the first 14 days of treatment with 200μg CIC-AQ was performed on 239 subjects, 18-64 years of age (CIC-AQ:N=121; placebo:N=118). P values were unadjusted for multiplicity.RESULTS: Improvement in overall RQLQ (LS mean change from baseline CIC-AQ=-1.18, placebo=-0.72, treatment difference=0.46 [95%CI 0.14, 0.79], p=0.005) and individual domains of activities, practical problems, nasal symptoms, emotional, sleep, and non-nose/eye symptoms (p<0.05 for all) were reported. Numerical improvements were reported for the individual domain of eye symptoms.CONCLUSION: In this analysis of subjects 18-64 years of age with SAR, improvements in the overall RQLQ score and individual domains of RQLQ were observed following 14 days of treatment with CIC-AQ 200μg QD. RATIONALE: Quality of life was evaluated in subjects 18-64 years of age with seasonal allergic rhinitis (SAR) following 14 days of treatment with ciclesonide aqueous nasal spray (CIC-AQ), an intranasal corticosteroid, as measured by the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). METHODS: This was an analysis of data from a double-blind, placebo-controlled, multicenter, efficacy and safety study of 327 subjects ≥12 years of age with SAR (Ratner et al, J Allergy Clin Immunol, 2006) who received 200μg CIC-AQ (N=164) or placebo (N=163) QD AM for 28 days. Subject-assessed overall RQLQ using a 7 point scale (0=not troubled to 6=extremely troubled) for days 1-14 was a secondary endpoint in this study. Subjects were not required to have a minimum baseline RQLQ score (mean baseline RQLQ=3.87). An analysis of improvement in overall RQLQ and individual domains of RQLQ following the first 14 days of treatment with 200μg CIC-AQ was performed on 239 subjects, 18-64 years of age (CIC-AQ:N=121; placebo:N=118). P values were unadjusted for multiplicity. RESULTS: Improvement in overall RQLQ (LS mean change from baseline CIC-AQ=-1.18, placebo=-0.72, treatment difference=0.46 [95%CI 0.14, 0.79], p=0.005) and individual domains of activities, practical problems, nasal symptoms, emotional, sleep, and non-nose/eye symptoms (p<0.05 for all) were reported. Numerical improvements were reported for the individual domain of eye symptoms. CONCLUSION: In this analysis of subjects 18-64 years of age with SAR, improvements in the overall RQLQ score and individual domains of RQLQ were observed following 14 days of treatment with CIC-AQ 200μg QD.

To describe the efficacy and safety of olopatadine HCl nasal spray 0.6% (OLO) when compared to its vehicle and azelastine HCl nasal spray 0.1% (AZE). This was a placebo (vehicle)- and active-controlled, double-masked, randomized, parallel group comparison of OLO versus vehicle and AZE in patients 12 years of age and older with a history of seasonal allergic rhinitis. After a vehicle run-in, patients were randomized (1:1:1) to two sprays BID for 16 days of OLO, vehicle, or AZE. Symptoms were recorded twice daily in an electronic diary. Efficacy assessments included average daily Total Nasal Symptom Scores (TNSS); safety was evaluated based on adverse events, nasal, physical, and cardiovascular parameters. 544 patients were randomized to treatment (21 US sites; Fall 2005). The average reduction from baseline in TNSS was 26.8%, 29.9%, and 18.4% for the OLO, AZE, and vehicle groups, respectively. OLO was superior to vehicle (p = 0.0029); there was no statistical difference between OLO and AZE (p = 0.2777). Generally, similar safety profiles were observed for OLO and AZE, with the exception of taste perversion (bad or bitter taste). Patients reporting incidence of taste perversion were significantly less in the OLO group than in the AZE group (p = 0.0500). The intensity of the taste perversion reported was also significantly lower in the OLO group than in the AZE group (p = 0.0052). OLO for two weeks was superior to placebo in the treatment of seasonal allergic rhinitis. There were no statistical or clinical differences between OLO and AZE, although side effects such as taste favor OLO.

This multicenter, randomized, double-blind placebo-controlled IRB-approved study was conducted to assess the quality of life and safety of olopatadine nasal spray (OLO), an H1 receptor antagonist and mast cell stabilizer, in the treatment of SAR in pediatric patients (consent/assent obtained). After a single blind placebo run-in period, 525 patients ages 6-11 years were randomized to either OLO 0.4% (N = 176), OLO 0.6% (N = 173) or vehicle placebo (PBO) (N = 176), 1 spray/nostril, BID for 2 weeks. Patient-reported outcomes were captured using the validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ). Safety assessments were also conducted. OLO 0.6%, dosed one spray twice daily, provided statistically significant improvement (p < 0.05) over PBO in the overall PRQLQ and nose, practical problems and activity domains. Overall, no safety issues were noted based upon a review of adverse events which included an assessment of incidence, seriousness, rate of patient discontinuation, and individual adverse event characteristics, as well as an analysis of changes from baseline for nasal examination parameters, general physical examination, and cardiovascular parameters. OLO 0.4% and 0.6%, dosed daily for 2 weeks, were safe and well tolerated in pediatric patients. OLO 0.6% provided statistically significant improvement in quality of life over PBO.

Background: A nasal spray containing the antiallergy agent olopatadine hydrochloride is being developed for the treatment of seasonal allergic rhinitis (SAR) to mountain cedar.Objective: To evaluate the safety and efficacy of 2 concentrations of olopatadine nasal spray vs placebo nasal spray in patients with SAR to mountain cedar.Methods: This was a multicenter, randomized, double-blind, placebo-controlled study. After a 3- to 21-day placebo run-in, 677 patients aged 12 to 81 years were randomized to receive 0.4% or 0.6% olopatadine or placebo, 2 sprays per nostril twice daily for 2 weeks. Patients evaluated morning and evening reflective and instantaneous nasal symptoms (sneezing, stuffy nose, runny nose, and itchy nose, which compose the total nasal symptom score [TNSS]) and ocular symptoms.Results: Olopatadine spray (0.4% and 0.6%) was statistically significantly superior to placebo for percentage change from baseline in overall reflective and instantaneous TNSSs. Also, 0.6% olopatadine was statistically significantly superior to placebo for reducing the reflective and instantaneous assessments of sneezing, runny nose, itchy nose, stuffy nose, itchy eyes, and watery eyes. Olopatadine spray exhibited a safety profile comparable with that of placebo.Conclusions: Olopatadine nasal spray (0.4% and 0.6%) provided statistically significant improvements in allergic rhinitis symptoms compared with placebo regarding TNSSs and individual symptoms, including congestion, itchy and runny nose, sneezing, and itchy and watery eyes, in patients with SAR to mountain cedar. Olopatadine nasal spray administered twice daily was safe and well tolerated in adolescents and adults.

Rationale Since SAR causes a considerable impact on QoL, the Rhinoconjunctivitis Quality of Life (RQLQ) Questionnaire was used to assess the QoL impact of olopatadine HCl nasal spray compared to the vehicle. Methods The 28-item RQLQ, consisting of 7 domains (activities, sleep, non-hayfever symptoms, practical problems, nasal symptoms, eye symptoms, and emotional), was used to collect QoL data during a multicenter, randomized, double-masked SAR (mountain cedar) trial comparing olopatadine HCl nasal spray, 0.6% and 0.4% against the olopatadine vehicle. Patients, recruited with at least a 2-yr history of non-recalcitrant SAR, filled out the questionnaire at baseline (randomization visit), and again after 2 weeks at the exit (end of treatment) visit. Results Olopatadine 0.6% (−1.1 + −1.4) and 0.4% (−1.1 + −1.3) nasal sprays were superior (p Conclusions Both olopatadine HCl nasal sprays are superior to vehicle in improving overall QoL. While patients receiving olopatadine HCl nasal spray, 0.6% had significantly demonstrable improvement in all areas of their life except non-hayfever symptoms, patients receiving olopatadine 0.4% nasal spray had significant improvement in 5 out of the 7 total QoL areas.